As per the US Code of Federal Regulation, the filing means FDA has made a threshold determination that the PAS is sufficiently complete to permit a substantive review. As previously communicated, the PAS is being reviewed under expedited Priority Review with a target action date of
About Reata
Reata is a global biopharmaceutical company committed to developing and commercializing novel therapeutics for patients with serious or life-threatening diseases with few or no approved therapies. We focus on molecular pathways involved in the regulation of cellular metabolism and inflammation. Reata developed the first and only
Forward-Looking Statements
This press release includes certain disclosures that contain 'forward-looking statements,' including, without limitation, our plans and objectives for the commercialization of SKYCLARYS and the timing thereof, our expectations regarding the size of the patient population for SKYCLARYS, and our plans to research, develop, and commercialize our other product candidates. You can identify forward-looking statements because they contain words such as 'believes,' 'will,' 'may,' 'aims,' 'plans,' 'model,' and 'expects.' Forward-looking statements are based on Reata's current expectations and assumptions. Important factors that could cause actual results to differ materially from those in the forward-looking statements include, but are not limited to, (i) the potential market size and the size of the patient population for SKYCLARYS and the market opportunities for SKYCLARYS; (ii) our ability to successfully build our commercial infrastructure to manufacture, market and sell SKYCLARYS, including the successful development and implementation of our sales and marketing campaigns for SKYCLARYS; (iii) the ability of our third-party suppliers and contract manufacturers to manufacture SKYCLARYS at the required quality and quantities and in compliance with applicable laws and regulations and (iv) other factors set forth in Reata's filings with the
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